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Trial record 1 of 1 for:    17690799 [PUBMED-IDS]
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Integrated Intervention for Substance Abusers With Depressive Disorders

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ClinicalTrials.gov Identifier: NCT00018655
Recruitment Status : Terminated (PI has been contacted numerous times for an update, with no response. ORD requested a close out of this project. 10/2011)
First Posted : July 5, 2001
Last Update Posted : December 10, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE July 3, 2001
First Posted Date  ICMJE July 5, 2001
Last Update Posted Date December 10, 2014
Study Start Date  ICMJE April 2000
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2009)
Hamilton Depression Scale, Timeline Follow-back (substance measure) [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00018655 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrated Intervention for Substance Abusers With Depressive Disorders
Official Title  ICMJE Integrated Intervention for Substance Abusers With Depressive Disorders
Brief Summary This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications.
Detailed Description This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications. Follow-up assessments were conducted at quarterly intervals for one year following treatment.
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Substance-Related Disorders
  • Depressive Disorder
Intervention  ICMJE
  • Behavioral: Twelve Step Facilitation
    Twelve Step Facilitation Therapy involves focusing on topics from 12-Step programs which support sobriety goals and personal growth.
  • Behavioral: Integrated Cognitive Behavioral Treatment
    Integrated Cognitive Behavioral Treatment involves focusing on thoughts, activities, and interactions with people related to depressive symptoms and/or substance use.
Study Arms
  • Experimental: Arm 1
    Twelve Step Facilitation
    Intervention: Behavioral: Twelve Step Facilitation
  • Experimental: Arm 2
    Integrated Cognitive Behavioral Treatment
    Intervention: Behavioral: Integrated Cognitive Behavioral Treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 13, 2009)
276
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Veterans age 18 and older with alcohol, cannabinol, and/or stimulant dependence and independent mood disorders will be included.

Exclusion Criteria:

Psychotic disorders

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00018655
Other Study ID Numbers  ICMJE MHBS-041-99S
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan Tate, PhD VA San Diego Healthcare System, San Diego
PRS Account VA Office of Research and Development
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP